Home NDC 0409-2587 Midazolam
Product NDC 0409-2587
11-digit product format 004092587
Labeler code 0409
Product ID 0409-2587_6c075a2d-b68b-41a7-aa0c-bcf9894e3f76
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MIDAZOLAM HYDROCHLORIDE
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Hospira, Inc.
Application ANDA075293
Marketing category ANDA
Marketing start 2006-02-02
Substance MIDAZOLAM HYDROCHLORIDE
Active strength 1 mg/mL
Pharmacologic classes Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0409-2587-53 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0409-2587-53 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0409-2587-53 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0409-2587-53 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0409-2587-53 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0409-2587-53 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0409-2587-53 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0409-2587-53 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0409-2587-53 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0409-2587-53 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0409-2587-53 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0409-2587-53 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075293-001 MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 A075293-002 MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A075293-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075293-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075293-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075293-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075293-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075293-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075293-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075293-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075293-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075293-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075293-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075293-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075293-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075293-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075293-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075293-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075293-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075293-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075293-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075293-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075293-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075293-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075293-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075293-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075293-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075293-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075293-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075293-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075293-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075293-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075293-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075293-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075293-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075293-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075293-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075293-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075293-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075293-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075293-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075293-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2000-06-20 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Midazolam
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MIDAZOLAM HYDROCHLORIDE 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination W7TTW573JJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311700 Internal RxNorm lookup 311702 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0409-2587-04 Midazolam 10 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 10 31 0409-2587-05 Midazolam 10 in 1 CARTON INJECTION, SOLUTION 10 31
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MIDAZOLAM HYDROCHLORIDE ACTIVE INGREDIENT W7TTW573JJ MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 MIDAZOLAM ACTIVE MOIETY R60L0SM5BC MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-2587 MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 28 Current NDC, Legacy NDC, 2 package rows 20241220_affecd4d-1f78-4bbe-5a8d-86849bbdc520.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE A-S Medication Solutions 5e85e477-d483-4345-8d7b-d7dcdc3e0652 2026-07-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075293 application number: ANDA075293 Midazolam MIDAZOLAM HYDROCHLORIDE Hospira, Inc. affecd4d-1f78-4bbe-5a8d-86849bbdc520 2026-04-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075293 application number: ANDA075293 ndc (product): 0409-2587 Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE A-S Medication Solutions b7effb82-e180-46f0-b2e8-a0d8ebc32a2a 2026-04-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075293 application number: ANDA075293 Midazolam MIDAZOLAM Henry Schein, Inc. 90f7b7f6-d0fd-40af-bbfa-70b152e3e27c 2025-10-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075293 application number: ANDA075293
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0409-2587-04 00409258704 10 mL in 1 VIAL, MULTI-DOSE 10 ml Historical 0409-2587-05 00409258705 10 VIAL, MULTI-DOSE in 1 CARTON (0409-2587-05) / 10 mL in 1 VIAL, MULTI-DOSE (0409-2587-04) 2006-02-02 0000-00-00 No No Current